New Jersey Veterans Memorial Home at Paramus, DAB CR6350 (2023)

DECISION

During the coronavirus disease of 2019 (COVID or COVID-19) pandemic, New Jersey Veterans Memorial Home at Paramus (Petitioner or facility), a skilled nursing facility (SNF) that participates in the Medicare program, permitted residents in its Dementia Unit, including COVID-positive residents, to congregate together without masks and without socially distancing themselves from each other.  Specifically, a surveyor, acting on behalf of the Centers for Medicare & Medicaid Services (CMS), observed this on April 20, 2020 and April 21, 2020, in the day room of the Dementia Unit.  When asked by the surveyor, facility staff in the day room stated that there was nothing that could be done to make the residents wear masks or socially distance themselves.

In addition, on April 11, 2020, facility staff incorrectly identified a deceased resident as the deceased resident’s roommate and, conversely, identified the living roommate as the deceased resident.  As a result, for a number of hours, facility staff believed the living roommate to be a different person.

Based on these incidents, and on others, CMS found Petitioner to be noncompliant with Medicare program participation requirements for SNFs and imposed a per-instance civil

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money penalty (CMP) on Petitioner.  In response, Petitioner sought review of CMS’s determination arguing that the facility managed its Dementia Unit consistently with Petitioner’s Infection Control Plan (ICP) and guidelines from the Centers for Disease Control and Prevention (CDC).  It also argued that no harm could come to the deceased resident whom facility staff misidentified.

As explained below, I conclude that Petitioner failed to fully implement its COVID-19 ICP because Petitioner permitted communal gatherings of residents in the day room and, as observed on April 20, 2020 and April 21, 2020, facility staff failed to make efforts to encourage and redirect residents in an attempt to socially distance them and/or have them wear masks.  My conclusion is solely based on the observed incidents in the day room.  It is not based on other allegations that CMS made in support of its charge that Petitioner failed to implement its COVID-19 ICP.

I also conclude that Petitioner was not in substantial compliance with Medicare program requirements when it misidentified a resident who died, resulting in the deceased resident’s roommate being misidentified as the resident who had died.  The misidentified living roommate was subject to the potential for more than minimal harm during the time that facility staff believed the living resident to be someone else.

Finally, I conclude that a per-instance CMP of $21,393 is appropriate and reasonable under the under the relevant statutory and regulatory factors.

I.  Legal Framework

The Medicare program “provides basic protection against the costs of . . . related post‑hospital . . . care” for individuals over the age of 65 who are eligible for Social Security retirement benefits and for individuals under 65 who meet other criteria.  42 U.S.C. § 1395c.  Post-hospital care includes extended care services provided at an SNF.  42 U.S.C. §§ 1395f(a)(2)(B), 1395x(h)-(i).

For Medicare program purposes, an SNF is an institution that is primarily engaged in providing skilled nursing care and/or rehabilitation services for its residents but is not primarily engaged in the care and treatment of mental diseases.  42 U.S.C. §§ 1395x(j), 1395i-3(a)(1).  Because an SNF is a “provider of services” in the Medicare program, each SNF that participates in the program must file a provider agreement with the Secretary of Health and Human Services (Secretary).  42 U.S.C. §§ 1395cc(a), 1395x(u).

In addition to complying with the terms of the provider agreement, a participating SNF must meet a variety of ongoing statutory requirements regarding how it provides services, maintains the rights of its residents, and administers its facility.  42 U.S.C. § 1395i‑3(a)(3), (b)-(d).  SNFs also must comply with “such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities

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thereof as the Secretary may find necessary.¹  42 U.S.C. § 1395i-3(d)(4)(B); see 42 U.S.C. § 1395i-3(c)(1)(xi), (f). The Secretary promulgated regulations to establish those additional requirements.  See 42 C.F.R. pt. 483, subpt. B.²

When an SNF fails to meet a statutory or regulatory participation requirement, then the SNF has a “deficiency.”  42 C.F.R. § 488.301; see 42 U.S.C. § 1395i-3(h)(1).  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  42 C.F.R. § 488.301.  To maintain “substantial compliance,” an SNF’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.

Broadly, noncompliance that subjects an SNF to enforcement remedies is divided into two levels.  One level comprises deficiencies that immediately jeopardize the health or safety of residents and the other level is composed of deficiencies that do not.  42 U.S.C. § 1395i-3(h)(1).  “Immediate jeopardy” exists when “the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.

The Secretary has the duty to enforce the statutory and regulatory participation requirements for SNFs.  42 U.S.C. § 1395i-3(f)(1).  To do so, the Secretary contracts with state agencies to conduct surveys to determine whether SNFs are in substantial compliance.  42 U.S.C. §§ 1395aa(a), 1395i-3(g); 42 C.F.R. § 488.10.  Standard surveys are unannounced and occur at least once every 15 months.  42 U.S.C. § 1395i‑3(g)(2)(A)(i), (iii)(I).  State agencies also conduct investigations into complaints against SNFs.  42 U.S.C. § 1395i-3(g)(1)(C), (4).  When the results of a survey show that an SNF is not in substantial compliance with program participation requirements, the Secretary may impose enforcement remedies on the SNF.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  When CMS selects an enforcement remedy to impose on an SNF, it determines the scope (i.e., the number of residents affected or potentially affected) and severity (i.e., the degree of harm or potential harm) for each deficiency.³ See 42 C.F.R. § 488.404(a)-(b).

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One such remedy is a CMP.  42 U.S.C. § 1395i-3(h)(2)(B)(ii).  CMS may impose a per‑instance CMP for each instance of the SNF’s noncompliance or a per‑day CMP for the number of days an SNF is not in substantial compliance.  42 U.S.C. § 1395i‑3(h)(2)(A), (B)(ii)(I); 42 C.F.R. § 488.430(a). For CMPs assessed on or after January 17, 2020, and for deficiencies that occurred after November 2, 2015, the CMP amounts may range as follows: $2,233 to $22,320 for per-instance CMPs; $112 to $6,695 per day for less serious noncompliance; or $6,808 to $22,320 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents.  45 C.F.R. § 102.3 (2020); 85 Fed. Reg. 2869, 2870, 2880 (Jan. 17, 2020); see also 42 C.F.R. § 488.438(a) (providing original CMP amounts before statutory inflation adjustments).

If CMS imposes a CMP based on a finding of substantial noncompliance, then the SNF may request a hearing before an administrative law judge (ALJ) to challenge CMS’s initial determination of noncompliance that led to the imposition of an enforcement remedy and/or the level of noncompliance (if a successful challenge to the level would affect the range of CMP amounts imposed on the SNF).  42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii); 42 C.F.R. §§ 488.330(e)(3)(ii), 488.408(g)(1), 488.434(a)(2)(viii), 498.3(b)(13)-(14), (d)(10); see also 5 U.S.C. §§ 554, 556.  However, CMS’s choice of remedies is not reviewable.  42 C.F.R. §§ 488.438(e)(2), 488.408(g)(2), 498.3(b)(13).

If an SNF challenges the existence of a deficiency, CMS must make a prima facie case that the SNF failed to substantially comply with federal participation requirements and, if CMS makes such a showing, the SNF must then prove substantial compliance by a preponderance of the evidence.  Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997); see Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson,129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001).  If an SNF challenges CMS’s determination as to the level of noncompliance, CMS’s determination must be upheld unless it is clearly erroneous.  42 C.F.R. § 498.60(c)(2).

If an ALJ concludes that there was a basis for imposing a CMP on an SNF, then the SNF may dispute the amount of the CMP.  The ALJ’s review of the CMP amount is limited to considering the statutory and regulatory factors for setting a CMP amount.  42 C.F.R. § 488.438(e)(3); see 42 U.S.C. §§ 1320a-7a(d), 1395i-3(h)(2)(B)(ii)(I); 42 C.F.R. § 488.438(f).  The ALJ may not reduce a CMP to zero.  42 C.F.R. § 488.438(e)(1).

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Either the SNF or CMS may seek administrative review of an ALJ’s decision.  42 C.F.R. § 498.80.

II.  Background and Procedural History

From April 19, 2020 through April 22, 2020, surveyors from Healthcare Management Solutions, LLC, acting on behalf of CMS, conducted a targeted infection control survey at Petitioner’s facility.  CMS Ex. 1 at 1.  On May 5, 2020, CMS notified Petitioner that the survey revealed that Petitioner was not in substantial compliance with Medicare requirements for SNFs and provided Petitioner with a Statement of Deficiencies (SOD).  CMS Ex. 2.  The SOD indicated that Petitioner was noncompliant with the following requirements and that the noncompliance immediately jeopardized the health and safety of residents:

• 42 C.F.R. § 483.10(a)(1), (2), (b)(1), (2) (F- Tag 550) (S/S = J) (Resident Rights/Exercise of Rights)

• 42 C.F.R. § 483.80(a)(1), (2), (4), (e), (f) (F- Tag 880 (S/S = L) (Infection Prevention and Control)

CMS Ex. 1.

In an August 24, 2020 initial determination, CMS imposed a $21,393 per-instance CMP on Petitioner based on the two deficiencies identified in the SOD.  CMS Ex. 25. 
On October 15, 2020, Petitioner filed a request for hearing before an ALJ in which Petitioner disputed that it was noncompliant with Medicare requirements for SNFs and that the noncompliance immediately jeopardized the health and safety of its residents.  On October 19, 2020, the Civil Remedies Division acknowledged Petitioner’s hearing request and issued my Standing Prehearing Order (SPO).  The SPO established prehearing submission procedures and submission due dates.

After granting CMS two extensions, on April 6, 2021, CMS filed its prehearing exchange consisting of a brief and motion for summary judgment along with 26 proposed exhibits.  Three of the exhibits were written direct testimony from witnesses (CMS Exs. 19-21).

After granting Petitioner three extensions, on December 3, 2021, Petitioner submitted a prehearing exchange that included a prehearing brief and opposition to summary judgment and 15 proposed exhibits.  Four of the exhibits were written direct testimony for witnesses (P. Exs. 8, 10, 12, 14).  Petitioner also requested to cross-examine all of CMS’s witnesses and objected to one of CMS’s witnesses serving as an expert.

CMS did not file a reply, any objections to Petitioner’s proposed exhibits or witnesses, or a request to cross-examine Petitioner’s witnesses.

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On February 7, 2022, I issued a Notice of Hearing in which I set a hearing for April 11, 2022, to permit Petitioner to cross-examine CMS’s witnesses.  As explained in the Notice of Hearing, I denied CMS’s summary judgment motion, overruled Petitioner’s objection to CMS’s expert witness, and admitted Petitioner Exhibits 1 through 15 and CMS Exhibits 1 through 26 into the record.

On April 11, 2022, I held a hearing at which Petitioner cross-examined CMS’s witnesses (Jacqueline Cronin, R.N. (CMS Ex. 19), Charles Walter (CMS Ex. 20), and Cari R. Levy, M.D. (CMS Ex. 21)).  I gave both parties an opportunity to file post-hearing briefs and required the parties to provide, in those briefs, all arguments that they wanted me to consider when rendering this decision.  Hearing Transcript (Tr.) 128-131; May 25, 2022 Notice of Receipt of Transcript and Order Scheduling Post-Hearing Briefing Schedule at 1.  Both parties timely filed post-hearing briefs (CMS Br. and P. Br.).

III.  Issues

1. Whether Petitioner was in substantial compliance with the Medicare program requirements for SNFs at 42 C.F.R. §§ 483.10(a)(1), (2), (b)(1), (2) and/or 483.80(a)(1), (2), (4), (e), (f).
2. If Petitioner was not in substantial compliance with Medicare program requirements, whether a $21,393 per-instance CMP is appropriate and reasonable under the statutory and regulatory factors for setting a penalty amount.  42 U.S.C. § 1320a-7a(d) and 42 C.F.R. § 488.438(f).

On February 7, 2022, I informed the parties that I could not review CMS’s immediate jeopardy finding in this case because CMS imposed a per-instance CMP on Petitioner.  Notice of Hearing at 2.  Although Petitioner did not object to my statement of the issues within the time allotted to file objections (see Notice of Hearing at 4), in post-hearing briefing, Petitioner stated that it is highly prejudicial for CMS to avoid review of the immediate jeopardy determination by imposing a per-instance CMP when the immediate jeopardy determination was clearly erroneous.  P. Br. at 33-34.

After reconsidering this matter, I continue to conclude that CMS’s immediate jeopardy determination is not reviewable in this proceeding.

Under the regulations, CMS’s immediate jeopardy determination is presumptively unreviewable:  “The finding that the [SNF’s] deficiencies pose immediate jeopardy to the health and safety of residents” is not an initial determination “and therefore not subject to appeal.”  42 C.F.R. § 498.3(d)(10)(i).  As a result, the only way that I can review the immediate jeopardy finding in this case is if there is a regulatory exception that authorizes such review.

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There are two exceptions to the prohibition on review of the immediate jeopardy finding.  The list of appealable initial determinations includes “the level of noncompliance found by CMS . . . but only if a successful challenge [to the immediate jeopardy finding] . . . would affect . . . [t]he range of civil money penalty amounts that CMS could collect . . .” or “[a] finding of substandard quality of care that results in the loss of approval for a SNF . . . of its nurse aide training program.”  42 C.F.R. § 498.3(b)(14).

Concerning the first exception, CMS had the option of imposing a per-instance CMP or a per-day CMP.  42 C.F.R. § 488.438(a).  A per-instance CMP means that CMS would pick an amount of money for the penalty within a single range from $2,233 to $22,320; however, a per-day CMP means that CMS would impose a CMP of $112 to $6,695 per day for less serious noncompliance or a CMP of $6,808 to $22,320 per day for noncompliance that posed immediate jeopardy to the health and safety of residents.  45 C.F.R. § 102.3 (2020); 85 Fed. Reg. 2869, 2870, 2880 (Jan. 17, 2020); see also 42 C.F.R. § 488.438(a) (providing original CMP amounts before statutory inflation adjustments).  In the present case, CMS imposed a per-instance CMP in the amount of $21,393.  CMS Ex. 25 at 1.  Therefore, even if I were to determine that CMS’s immediate jeopardy determination was clearly erroneous, such a finding would not change the range of CMP amounts that could be imposed on Petitioner.  This would only happen if CMS had imposed a per-day CMP.  As a result, the first exception does not apply in this case.  See Fort Madison Health Ctr., DAB No. 2403 at 12 (2011).

As to the second exception, Petitioner may have a basis for review of the immediate jeopardy determination.  However, this is not clear from the record.  Further, even if it was clear, for the reason stated below, such review would be moot.

CMS’s notice of initial determination indicated that one of the deficiencies in the case (i.e., 42 C.F.R. § 483.10(a)(1)-(2), (b)(1)-(2)) involved substandard quality of care.  CMS Ex. 25 at 1.  That notice also stated that SNFs are prohibited from receiving approval for a nurse aide training and competency program (NATCEP) for two years when the SNF was subject to a partially extended survey, and the notice indicated Petitioner was prohibited for two years from having a NATCEP.  CMS Ex. 25 at 5.  While it is true that a finding of substandard quality of care during a standard survey requires the state agency to extend the survey, the survey in the present case was not a standard survey.  42 U.S.C. § 1395i-3(g)(2)(B)(i).  If the survey conducted in this case was an “abbreviated standard survey,” then a “partial extended survey” may be conducted to evaluate “additional participation requirements subsequent to finding substandard quality of care during an abbreviated standard survey.”  42 C.F.R. § 488.301.  However, there is no express documentation indicating that a partial extended survey was undertaken or completed.  See CMS Exs. 1-2, 19, 25.  In addition, the record does not expressly indicate that Petitioner lost approval for an existing NATCEP, just that Petitioner was prohibited from receiving approval for a NATCEP for two years.

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Even if Petitioner met the exception permitting review of the immediate jeopardy finding under 42 C.F.R. § 498.3(b)(14)(ii) (i.e., loss of approval for a NATCEP due to a finding of substandard quality of care), review of the immediate jeopardy determination would be moot.  This is because a state agency cannot approve a NATCEP/must withdraw approval from a NATCEP when an SNF has been assessed a CMP that is more than $11,160.  42 U.S.C. § 1395i-3(f)(2)(B); 42 C.F.R. § 483.151(b)(2)(iv); 85 Fed. Reg. 2,869, 2,886 (Jan. 17, 2020) (inflation adjusted amount listed under statutory entry for 42 U.S.C. § 1396(f)(2)(B)(iii)(I)(c)).

As explained below, I uphold the $21,393 per-instance CMP that CMS imposed on Petitioner.  Therefore, even if I were to review and reverse CMS’s finding of immediate jeopardy in this case, it would not result in the reinstatement of approval of a NATCEP.  Thus, review of the immediate jeopardy determination is moot in this case. 

IV.  Findings of Fact, Conclusions of Law, and Analysis

Infectious Disease Control and Prevention Deficiency

1. COVID-19 is a highly contagious virus that primarily spreads through respiratory droplets expelled by infected individuals when those individuals breathe, speak, cough, or sneeze.  COVID-19 may also be transmitted when individuals touch a contaminated surface and then touch their mouths, noses, or eyes.  COVID-19 is especially dangerous in the nursing home environment due to the number of individuals living together in a facility and the fact that many of those individuals have underlying medical conditions that make them more vulnerable to negative outcomes if infected with COVID-19. 

The state agency survey in this matter took place from April 19, 2020 through April 22, 2020.  CMS Ex. 1 at 1.  The survey was a COVID-19 Infection Control Focus Survey, which was conducted to determine whether Petitioner was addressing COVID-19 in accordance with federal requirements.  CMS Ex. 19 ¶¶ 2-3.  At the time of the survey, COVID-19 was “a new disease.”  CMS Ex. 19 ¶ 3; see also Tr. 74.

COVID-19 is a highly contagious virus that is spread by respiratory droplets expelled when an infected person breathes, talks, coughs, sneezes, or sings, and other persons either inhale those droplets through the nose, mouth, airways, or lungs, or they touch surfaces contaminated with those droplets and then touch their mouths, noses, or eyes.  CMS Ex. 21 ¶ 4.  Further, COVID-19 “has a broad clinical presentation, long incubation period, and is transmissible through asymptomatic or pre-symptomatic people, including patients/residents and healthcare personnel (HCP).”  P. Ex. 3 at 1.

Residents in SNFs are at particular risk from COVID-19.  CDC stated that SNFs “are unique, as they serve both healthcare providers and as full-time homes for some of the

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most vulnerable Americans.”  CMS Ex. 3 at 1.  Further, CDC stated that, “[g]iven their congregate nature and resident population served (e.g., older adults often with underlying chronic medical conditions), nursing home populations are at high risk of being affected by respiratory pathogens like COVID-19.”  P. Ex. 2 at 1.

Each of the parties’ expert witnesses agree with CDC’s assessment.  Cary R. Levy, M.D., Ph.D.,⁴ testified that:

Nursing homes are particularly susceptible to COVID-19 outbreaks due to the high density population, the likelihood that staff members work at multiple facilities, the use of shared rooms, and the prolonged contact between residents and health care providers.  Furthermore, nursing home residents are particularly vulnerable to severe consequences from COVID-19 due to their age and underlying health conditions.

CMS Ex. 21 ¶ 4.

Ronald G. Nahass, M.D.,⁵ testified that he had “never seen the intensity and severity of an outbreak of a highly transmittable and lethal infectious disease like COVID19.”  P. Ex. 10 ¶ 14.  Dr. Nahass further testified that nursing facilities “had limited to no capacity to properly isolate patients in private rooms let alone airborne isolation which was the

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preferred approach.”  P. Ex. 10 ¶ 14.  Dr. Nahass also testified that “the elderly patients with early or advanced physical or cognitive decline that resided in [Petitioner’s facility] or other [SNFs] in the state of [New Jersey] were the most vulnerable and the statistics of the pandemic in this state at the time document this clearly.”  P. Ex. 10 ¶ 15.

2. At the time of the survey, Petitioner had an ICP in place related to COVID-19.  In general, the ICP provided that COVID-19 positive residents, COVID-19 suspected residents, and COVID-19 negative residents, would be separated from each other.  All group activities at the facility were to be cancelled.  Further, staff were to encourage residents to remain in their rooms; however, if residents left their rooms, residents were to wear masks, limit their movements, practice hand hygiene, and maintain social distancing (six feet) with other individuals.  For residents in the Dementia Unit, the ICP acknowledged that those residents would wander, but required staff to set up smaller areas in which residents could wander to reduce the number of residents interacting with each other.  The CMS surveyor found that Petitioner’s ICP met federal regulatory requirements. 

Petitioner utilized a COVID-19 Infection Prevention and Control Program for New Jersey Veterans Homes as its ICP for COVID-19.  CMS Ex. 4.  This ICP was revised in April 2020.  CMS Ex. 4 at 9.  The CMS survey found that Petitioner’s ICP met the requirements of 42 C.F.R. § 483.80.  Tr. 26; see also P. Ex. 10 ¶ 11 (Petitioner’s ICP closely follows CMS, CDC, and NJ DOH guidance).  The stated purpose of the ICP was to implement infection control interventions in compliance with CDC and CMS guidelines.  CMS Ex. 4 at 1.

The COVID-19 ICP contained numerous provisions, including the following:

• Petitioner “shall cancel all . . . group activities, . . . and communal dining during the period of the COVID-19 pandemic.”  CMS Ex. 4 at 1; see also P. Ex. 10 ¶ 10.

• “Residents developing respiratory symptoms will be isolated in a private room, with the door shut (can cohort with residents with suspected or confirmed COVID-19).”  CMS Ex. 4 at 2.

• “Upon notification of a positive COVID-19 test result, the facility will relocate the resident with the confirmed COVID-19 diagnosis, to the extent possible, to a designated area of the unit or designated unit within [Petitioner’s facility].  The transfer of the resident with confirmed COVID-19 will occur as soon as practical to provide a safe relocation of the resident.”  CMS Ex. 4 at 3.

• “The [facility] will assign dedicated staff to a resident(s) on a unit(s)/location in the [facility] that have a presumed or confirmed COVID-19 diagnosis, with staff not being assigned to other units (to the extent possible).”  CMS Ex. 4 at 3.

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• “[The facility] will make every attempt, to locate/relocate suspected or confirmed COVID-19 residents to perspective units/areas where other suspected or confirmed COVID-19 residents reside, separate from residents who do not have symptoms or known exposure to COVID-19.  The [facility] will attempt (as possible) to keep symptomatic residents pending test results separate from residents with a C[OVID]-19 diagnosis and asymptomatic residents.”  CMS Ex. 4 at 3 (emphasis added).

• “Residents with confirmed COVID-19 will be placed in a single room, or may cohort with another resident with confirmed COVID-19.  Residents with suspected/confirmed COVID-19 must remain in their rooms with the door closed with a red stop sign posted outside the door.”  CMS Ex. 4 at 3 (emphasis added).

• “The roommate of a resident that becomes confirmed positive for COVID-19 shall not be moved in with another resident, as he/she is considered exposed to and then may spread the virus.”  CMS Ex. 4 at 3 (emphasis added).

• “The [facility] will locate, to the extent possible, symptomatic residents and those pending test results in a separate unit/area until their COVID-19 status is known.  If the locations of COVID-19 suspected residents are in other areas of the facility, the resident’s door will remain closed.  At the discretion of the facility, a yellow stop sign may be placed outside the door.”  CMS Ex. 4 at 4.

• “Staff shall restrict residents (to the extent possible) to their rooms, except for medically necessary purposes.  If residents must leave their room, residents shall: 1. Wear a facemask[;] 2. Perform hand hygiene[;]  3. Limit their movement in the [facility;] 4. Maintain social distancing (6 feet away from others)[.]”  CMS Ex. 4 at 4 (emphasis added).

• Residents who are not infected with COVID-19 will be encouraged to remain in their rooms as much as possible; however, “[i]f the resident leaves their room, they shall wear a facemask, perform hand hygiene and maintain social distancing (at least six feet apart from others)[.]”  CMS Ex. 4 at 4 (emphasis added).

• Further, facility staff is to “[s]et up smaller distances for residents to ambulate in dementia units where residents wander, in order to reduce the number of residents interacting with other residents.”  CMS Ex. 4 at 4 (emphasis added); see also P. Ex. 10 ¶ 10.

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3. CMS and CDC issued guidance documents to address COVID-19 infection control practices for nursing homes.  In general, these guidance documents recommended that SNFs cohort residents based on their COVID-19 infection status (i.e., COVID-positive, COVID-negative, COVID-suspected or unknown).  CDC stated SNFs could decide whether to move COVID-positive residents in memory care units to a COVID-positive unit or to keep COVID-positive residents in the memory care units with other residents.  However, CDC included that the facility’s memory care unit staff needed to make an effort to ensure that residents wore masks and socially distanced from each other. 

On May 12, 2020, CDC issued an updated version of a guidance document entitled Consideration for Memory Care Units in Long-Term Care facilities.⁶  P. Ex. 4.  CDC recognized that strategies to prevent the spread of COVID-19 in dedicated memory units are especially challenging to implement because “residents can have a difficult time following recommended infection prevention practices such as social distancing, washing their hands, avoiding touching their face, and wearing a cloth face covering for source control.”  P. Ex. 4. at 1.

Further, although CDC and CMS generally recommended establishing a designated COVID-19 care unit with confirmed COVID-19 positive residents (P. Ex. 1 at 1; P. Ex. 2 at 5; P. Ex. 3 at 1; CMS Ex. 3 at 3), due to special considerations for residents with dementia, CDC indicated that facilities could choose whether to keep all residents in a memory care unit despite their COVID-19 infection status.  P. Ex. 4 at 2.

The CDC’s COVID-19 recommendations for memory care units included the following:

• “Routines are very important for residents with dementia.  Try to keep their environment and routines as consistent as possible while still reminding and assisting with frequent hand hygiene, social distancing, and use of cloth face covering (if tolerated).”  P. Ex. 4 at 1 (emphasis added); see also P. Ex. 2 at 3 (CDC generally recommending that all residents in an SNF wear a cloth face covering or facemask, if tolerated, when they leave their room).

• “Continue to provide structured activities, which may need to occur in the resident’s room or be scheduled at staggard times throughout the day to maintain social distancing.”  P. Ex. 4 at 1 (emphasis added).

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• “Provide safe ways for residents to continue to be active, such as personnel walking with individual residents around the unit or outside.”  P. Ex. 4 at 1 (emphasis added).

• “Limit the number of residents or space residents at least 6 feet apart as much as feasible when in a common area, and gently redirect residents who are ambulatory and are in close proximity to other residents or personnel.”  P. Ex. 4 at 1 (emphasis added).

• On April 20, 2020, the CMS surveyor observed ten residents seated in the “day room” of the facility’s Dementia Unit without masks and without being socially distanced from each other.  Included in this group of residents was R9,⁷ a COVID-positive resident, seated next to a COVID-negative resident.  The surveyor asked the certified nursing assistant (CNA) present (i.e., CNA26) about this situation and CNA26 stated that there was nothing that could be done because residents in the Dementia Unit would not stay in their rooms or wear masks.  On April 21, 2020, the CMS surveyor saw 15 residents in the Dementia Unit day room.  The surveyor observed R9, R10, R11, and R12, all of whom were COVID-positive residents, to be ambulating around the day room and/or seated with other residents, of unknown COVID status, at tables in the day room without masks.  The surveyor asked the CNA present (i.e., CNA27) about this situation and CNA27 stated that the dementia unit residents wander and cannot be separated. 

Jacqueline Cronin, R.N.,⁸ was one of the surveyors who conducted the April 2020 survey at Petitioner’s facility.  Surveyor Cronin testified that she observed the following on April 20, 2020 and April 21, 2020:

On April 20, 2020 at 7:30 p.m., I observed the secured dementia unit and saw 10 residents seated in the dayroom. The residents were not wearing face masks or social distancing.  Resident # 9 was identified to me by the CNA

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# 26 as being positive for COVID-19.  I observed Resident # 9 seated in a chair next to another resident who was identified as being COVID-19 negative.  CNA # 26 said “what are we supposed to do?  This a dementia unit and they [the residents] won’t stay in their rooms or wear a mask.”

* * * * *

On April 21, 2020 at 12:50 p.m., I observed approximately 15 residents seated in the dayroom on the secured dementia unit. At that time, I interviewed CNA # 27 and CNA # 28.  They stated that four of the residents (Resident #9, Resident #10, Resident # 11, and Resident # 12) in the dayroom were positive for COVID-19.  These four residents were not wearing facemasks.  I observed Resident #9 ambulating throughout the dayroom, and the resident was seated next to other residents with an unknown COVID-19 status.  I observed Resident # 10 and Resident # 11 seated at a round table with a resident with unknown COVID-19 status.  I observed Resident # 12 seated in a wheelchair placed at a rectangular table with three residents with unknown COVID-19 status.  CNA # 27 told me “this is a dementia unit.  We can't keep the residents separated because they wander.”

CMS Ex. 19 ¶¶ 26, 28 (citations omitted) (emphasis added); see also CMS Ex. 1 at 21.

The medical records for R9, R10, R11, and R12 show that each resident tested positive for COVID-19:

• Based on a specimen taken on April 9, 2020, on April 11, 2020, a laboratory informed Petitioner’s facility that R9 had tested positive for COVID-19.  CMS Ex. 11 at 5, 13.

• Based on a specimen taken on April 9, 2020, on April 11, 2020, a laboratory informed Petitioner’s facility that R10 had tested positive for COVID-19.  CMS Ex. 12 at 7, 9.

• Based on a specimen taken on April 11, 2020, on April 16, 2020, a laboratory informed Petitioner’s facility that R11 had tested positive for COVID-19.  CMS Ex. 13 at 6, 12.

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• Based on a specimen taken on April 15, 2020, on April 20, 2020, a laboratory informed Petitioner’s facility that R12 had tested positive for COVID-19.  CMS Ex. 14 at 5, 8.

When asked at the hearing to provide a more detailed description of the events observed in the day room, Surveyor Cronin testified as follows:

I remember first observation, going down to -- onto the dementia unit, and it was a large activity/dining room that was open, had multiple residents in the room.  None of them wearing face masks.  They were not social distanced.  They had -- there was a staff member in that room that was in full PPE, meaning the gowns, I don’t remember about gloves, but gowns, N95 and eye protection, sitting in the dayroom with the residents.

The residents were -- some were wandering.  Some were coughing.  Some -- they were seated next to each other.  A lot of the residents -- some of the residents were not
independently ambulatory, so the staff would have had to have placed them.  They were in wheelchairs.  They would have had to have placed them at the tables together without socially distancing.

And it’s in the Statement of Deficiencies where specific residents who were positive were seen to be wandering from table to table, you know, sitting down next to residents, patting them on the back, talking, you know, just interacting with the other residents.

When I interviewed the CNA who was there in her full PPE, I asked her if there were positive residents, any residents who were positive in the room, and she quickly identified them.  And I believe one of them was the one that was ambulating
throughout the room, and one was coughing.

And I said, well, what about social distancing or face mask, what are you doing to, you know, to help try to mitigate the spread?  And she said, well, what can we do?  They have dementia.  They will not -- they won’t practice socially distancing.  They won’t wear a face mask.  It was the attitude of what, you know, well, she said it, what can we do.

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There’s nothing we can do about trying to mitigate the spread of COVID-19 within the dementia unit.

* * * * *

[The CNA] did nothing to encourage the residents to wear a face mask.  I didn’t even see face masks in the room.  She did nothing to encourage them to step away from each other, to, you know, sit spatially, you know, six feet apart.  She did nothing to, you know, provide a tissue or something like that to the resident who was coughing.  She didn’t move them away from each other, the ones that had to -- were dependent for their locomotion on the unit.  She did -- she did nothing.

Tr. 61-63 (emphasis added).

5. Petitioner was not in substantial compliance with infection control regulations at 42 C.F.R. § 483.80(a)(1)-(2) (F-Tag 880) because facility staff failed to fully implement Petitioner’s ICP.  Facility staff failed to close or limit access to the Dementia Unit’s day room resulting in residents, some of whom were COVID-positive, congregating in the day room in close proximity to each other without masks.  Having decided to allow Dementia Unit residents to congregate in the day room under the supervision of facility staff, on April 20, 2020 and April 21, 2020, facility staff failed to encourage/facilitate social distancing or mask wearing, as required by the ICP. 

The Social Security Act (Act) states that an SNF must:

Establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment in which residents reside and to help prevent the development and transmission of disease and infection.

42 U.S.C. § 1395i-3(d)(3)(A); see also 42 C.F.R. § 483.80.  The Secretary’s regulations require facilities to establish and maintain an infection control program that includes, among other things, a “system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to § 483.70(e) and following accepted national standards.” 42 C.F.R. § 483.80(a)(1).

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The statutory and regulatory injunction to “establish and maintain” an ICP requires SNFs to not only adopt an appropriate ICP, but also to implement the program’s prescribed precautions.⁹  Golden Living Ctr. - Superior, DAB No. 2768 at 7 (2017) (citing Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12 (2014)).

In the present case, CMS only alleges that Petitioner failed to fully implement its ICP and not that the Petitioner failed to establish an adequate ICP.  See Tr. 81-82.

One of the general allegations in the SOD supporting a deficiency under 42 C.F.R. § 483.80 is that Petitioner failed to cancel communal activities and dining on the facility’s Dementia Unit resulting in COVID-positive residents R9, R10, R11, and R12 interacting with residents of unknown COVID status.  CMS Ex. 1 at 15; CMS Ex. 19 ¶ 6.  However, the SOD’s specific allegations involved a failure of Petitioner’s staff on April 20, 2020 and April 21, 2020, to follow the ICP and attempt to have residents wear masks and socially distance while congregating together in the day room.  CMS Ex. 1 at 21.  As provided in detail above, Surveyor Cronin testified consistently with and in support of those observations in the Dementia Unit day room.

In addition, the SOD alleged, in support of the 42 C.F.R. § 483.80 deficiency, that Angela Lattie, R.N., the charge nurse for Petitioner’s Dementia Unit, told Surveyor Cronin on April 21, 2020, that:  the Dementia Unit residents ate their meals and congregated in the dayroom; the facility had not provided staff with additional guidance or policies regarding infection control for the Dementia Unit; and Dementia Unit residents were not able to maintain social distancing, wear facemasks, or stay in their rooms due to their dementia.  CMS Ex. 1 at 22; CMS Ex. 19 ¶ 30.

In response to these allegations in the SOD, Nurse Lattie provided written testimony in this case.  See P. Ex. 12.  Nurse Lattie denied that she told Surveyor Cronin that facility staff were not educated on infection control for dementia residents, that residents were unable to monitor social distancing or wear masks, and that the residents ate meals and congregated in the dayroom.  P. Ex. 12 ¶¶ 4, 6, 13; P. Ex. 13 at 1.  Nurse Lattie testified that, because the facility cannot restrain residents, “if a resident in the Dementia Unit wandered into the day room while eating, they were repeatedly encouraged to return to their room to finish their meal.”  P. Ex. 12 ¶ 7.  Nurse Lattie further testified:  “At all times, including during meals, residents in the Dementia Unit were directed to practice

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social distancing, and guided away from another to the extent possible.  Staff members made all possible efforts to prevent residents from congregating in groups.”  P. Ex. 12 ¶ 9.  Nurse Lattie also testified that “all residents in the Dementia Unit were provided with face coverings,  If one resident took off their face covering, they were encouraged, time and time again, to put their mask back on.”  P. Ex. 12 ¶ 10.

Because CMS neither cross-examined nor objected to Nurse Lattie’s testimony, I accept her denials concerning alleged statements that she made as to allowing communal dining in the day room and the facility’s failure to provide guidance to Dementia Unit staff.  Concerning the SOD’s allegation of resident meals in the day room, Surveyor Cronin testified that she did not personally observe meals being served or entertainment/ activities being provided.  Tr. 46.  Therefore, I do not accept those allegations as proven. 

However, I conclude that Petitioner did not expressly come forward with evidence that Surveyor Cronin’s observations of the day room on April 20, 2020 and April 21, 2020, i.e., that many residents, including COVID-positive residents, were seated at tables or ambulating around the day room without masks or social distancing, was inaccurate.  Petitioner did not provide written direct testimony from the CNAs to contradict that Surveyor Cronin spoke with them on those dates or other witnesses who could contradict Surveyor Cronin’s observations.  Further, while Nurse Lattie testified that staff would make all efforts to prevent residents congregating in groups and would encourage residents to wear masks, Nurse Lattie’s testimony never specifically refuted Surveyor Cronin’s observations on April 20, 2020 and April 21, 2020.  As a result, I accept Surveyor Cronin’s testimony as to the events she observed in the day room as true, including statements that the CNAs made in response to Surveyor Cronin’s questions.

Petitioner’s defense primarily focuses on denying that Petitioner continued to hold communal dining and activities, that Nurse Lattie’s testimony refutes much of the SODs allegations; that the CDC guidance acknowledges that “achieving social distancing, universal masking, and zero interaction between residents within a memory [unit] is highly improbably, if not impossible”; that CDC did not recommend closing off all common areas in memory units; and that CMS’s and Petitioner’s witnesses acknowledged and testified that it was difficult to maintain masking and social distancing in memory units.  P. Br. at 23-31.

In support of Petitioner’s defense, Dr. Nahass testified that one of the biggest challenges for Dementia Units within SNFs is the inability to confine those residents and that, as a result, they frequently wander about the unit.  P. Ex. 10 ¶ 23.  Dr. Nahass also opined that it is extraordinarily difficult to get residents in the Dementia Unit to wear masks.  “This situation created [an] additional challenge regarding limiting the spread of COVID-19 and put such units at great risk.”  P. Ex. 10 ¶ 23.  Dr. Nahass testified that Petitioner “had the requisite [infection control] policies in place” and “[t]he challenge for care that is the

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nature of the [SNF] environment and is not a failure to follow their policy.”  P. Ex. 10 ¶¶ 23-24.

Petitioner’s other expert witness, Shawna Maraj,¹⁰ testified that CDC recognized the difficulty in implementing and enforcing COVID-19 infection control policies on residents in dementia units P. Ex. 9 ¶¶ 34-38.

Petitioner’s arguments and the testimony of its expert witnesses are insufficient to show that it fully complied with its IPC.  The record is clear that residents in a memory care unit will not easily conform to the best COVID-19 infection control practices.  That fact does not help Petitioner.  Rather, it means that Petitioner’s staff needed to comply with the IPC and CDC guidance for memory care units and encourage residents to wear masks and re-direct residents to avoid residents grouping closely together, especially if they did not wear masks and some residents were known to be COVID-positive.  Petitioner may believe that such an effort was futile or the goal of keeping the residents safe from COVID-19 was impossible, but the ICP and CDC guidance for memory care units required staff to make the effort.  In fact, Nurse Lattie testified that staff should be and making such an effort.  P. Ex. 12 ¶¶ 7, 9-10.  But, as Surveyor Cronin testified (as quoted earlier), the CNAs observed on April 20, 2020 and April 21, 2020 had given up trying to stop residents from congregating in the day room closely together without masks.

As provided in detail above, Petitioner’s ICP generally required residents to stay in their rooms but, if they left their rooms, the ICP required them to wear masks and socially distance.  CMS Ex. 4 at 4.  There is no reason to conclude that this provision did not apply to the Dementia Unit.  Importantly, the ICP contained a provision specific to the Dementia Unit, requiring facility staff to “[s]et up smaller distances for residents to ambulate in dementia units where residents wander, in order to reduce the number of residents interacting with other residents.”  CMS Ex. 4 at 4; see also P. Ex. 10 ¶ 10.  This provision is significant because it accounts for the fact that residents with dementia will likely wander, and it directs staff to act to reduce resident interaction.

The ICP is consistent with CDC guidance for memory care units.  As Petitioner summarized it:

For example, at that time, the CDC recommended that [SNFs]:  (1) limit the number of residents or space residents at least six feet apart as much as feasible when in a common area, and gently redirect residents who are ambulatory and are

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in close proximity to other residents or personnel; and (2) frequently clean often-touched surfaces in the memory care units where residents and staff spend a lot of time.  See P Ex. 4 pg. 1.

P. Br. at 26; P. Ex. 8 ¶ 37 (Expert witness Maraj acknowledging that CDC guidance concerning social distancing made staff responsible to redirect residents in memory care units).  Petitioner is correct, CDC expected staff to act in order to keep residents in memory care units socially distanced.

Despite this, Dr. Nahass testified that Petitioner did not fail to comply with its ICP just because the care for the residents in the Dementia Unit was challenging.  P. Ex. 10 ¶ 24.  Petitioner asserts in briefing that “[w]hat Ms. Cronin observed in the dementia unit was exactly what was contemplated by the CDC.”  P. Br. at 28.

I disagree with Dr. Nahass’ view that Petitioner’s staff complied with its ICP.  Further, the situations that Surveyor Cronin observed in the day room were exactly the opposite to what CDC contemplated in its guidance.  Although attempting to ensure that memory care unit residents follow COVID-19 precautions was extremely challenging, it is clear that the ICP and CDC guidance for memory care units required facility staff to take action to try to make sure residents socially distanced from each other and wore masks.  Further, CDC guidance required vigilance and effort by staff to continually redirect Dementia Unit residents from congregating too close to each other.  As Dr. Nahass admitted, Petitioner’s ICP provided “appropriate protocols to reduce risk from communal activities by having residents not infected with COVID-19 remain in their rooms, wear facemasks outside their rooms and maintain social distancing, including specific mention that the facility will attempt to reduce the number of residents interacting with other residents in dementia units.”  P. Ex. 10 ¶ 10 (emphasis added).  On April 20, 2020 and April 21, 2020, facility staff made no such attempt.

To be clear, I uphold the 42 C.F.R. § 483.80 deficiency because facility staff, as observed on April 20, 2020, and April 21, 2020, failed to encourage masking and redirect residents so they would socially distance, as required by the ICP and CDC.  I do not uphold the deficiency simply because residents had wandered into the day room or because facility staff unsuccessfully kept residents masked or socially distanced.  Staff made clear to Surveyor Cronin that it was no use to even try any longer.

Petitioner appears to focus a portion of its defense on arguing that it did not hold communal activities in the day room and that Surveyor Cronin incorrectly opined that Petitioner could have controlled the situation by closing the day room.  It is true that Surveyor Cronin testified that the deficiency was based on a failure to cancel communal activities and that Petitioner “could have simply closed the dayroom to prevent residents from congregating without masks or social distancing, as the facility did as part of its

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plan for removing immediate jeopardy.”  Tr. 66-67; CMS Ex. 1 at 21; CMS Ex. 19 ¶ 26; see also CMS Ex. 21 ¶ 35.  However, Surveyor Cronin also testified that Petitioner did not need to close the day room so long as Petitioner took steps to mitigate transmission of COVID-19, such as social distancing and wearing a mask.  Tr. 67.

Surveyor Cronin acknowledged that there are difficulties in instituting and enforcing infection control policies within dementia units and that CDC recognized that individuals with dementia would have difficulty social distancing and wearing face coverings.  Tr. 42.  Surveyor Cronin agreed that the CDC guidance acknowledged that residents with COVID-19 in memory care units would wander around.  Tr. 44.  However, Surveyor Cronin thought staff members were obligated to remind and assist residents with the use of cloth face coverings (if tolerated).  Tr. 42.  Surveyor Cronin stated that staff in the Dementia Unit cannot restrain residents, use physical force to make them wear masks, and cannot lock residents in their rooms to ensure social distancing.  Tr. 43.  However, Surveyor Cronin said that staff can gently redirect residents, encourage social distancing, and remind them to wear masks.  Tr. 43.

On cross-examination, Dr. Levy testified in the affirmative when Petitioner’s counsel asked her if facility staff could gently redirect residents, encourage social distancing, and remind residents to wear their masks.  Tr. 103.  On redirect, Dr. Levy also testified as follows:

Q. All right, so does the fact that a dementia population is more difficult to deal with in the time of a pandemic – does the preclude the facility from a duty to try to mitigate the
spread of COVID among a dementia population? 
A. It does not. 
Q. In fact, one thing that they could do would be to – one thing that they could do to attempt to spread -- to mitigate the spread of COVID would be to close the dayroom, right? 
A. Correct. 
Q. That would be one option?  Now what if you chose to keep the dayroom open, would you expect the staff to attempt to keep the positive residents away from the negative residents? 
A. I think that’s not realistic.  So in using engineering controls to separate people naturally would be the goal. 
Q. Well, but I mean, let’s say that you had a non-ambulatory resident.  Would it be advisable for a CNA to place the non ambulatory positive resident at a table next to a non
ambulatory negative resident? 
A. That would not be advised. 
Q. Okay, and if you did have a wandering ambulatory resident in the dayroom who was positive, I mean would it be

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advisable for a CNA perhaps to just take the resident by the hand and steer them away from a resident who might be negative in the room? 
A. Yes. 
Q. Okay. And as a general matter, I mean, you could still have structured activities for a dementia population in the residents’ room? 
A. Correct.

Tr. 111-13.

Dr. Levy also testified in greater detail about the concept of “engineering controls,” which include simple actions such as moving chairs in the day room so they were six feet apart or limiting the number of chairs in the day room and placing chairs in other rooms to disperse the resident population.  Tr. 121-22.  I note that Petitioner’s ICP endorses “engineer controls” for the Dementia Unit when it stated:  “Set up smaller distances for residents to ambulate in dementia units where residents wander, in order to reduce the number of residents interacting with other residents.”  CMS Ex. 4 at 4.

There can be no doubt that Petitioner’s staff allowed the Dementia Unit residents to be endangered when staff stopped trying to separate residents and encourage them to wear masks.  As Dr. Levy testified:  “Yeah, the current thought is that transmission is predominantly through respiratory means, so coughing, sneezing, breathing in a confined space, and that that’s how the disease is transmitted.”  Tr. 118.  Dr. Levy also testified that “being in the same room for a prolonged period of time is particularly problematic, which is why the cohorting recommendations were put in place . . . .”  Tr. 120.  The residents observed on April 20, 2020 and April 21, 2020, were unmasked, in close contact with each other, in the presence of COVID-positive residents and residents of unknown COVID status.  As discussed earlier, the parties’ experts agreed that COVID-19 was particularly grave when contracted by nursing home residents.¹¹  Therefore, Petitioner was not in substantial compliance with 42 C.F.R. § 483.80 because Petitioner’s failure to fully implement its ICP posed a risk for more than minimal harm to its residents.¹²

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Resident Rights Deficiency

6. On April 9, 2020, R7 and R8 tested positive for COVID-19.  Petitioner’s staff relocated R7 and R8 from their originally assigned rooms in the facility to a new room to cohort them together.  On April 11, 2020, R7 passed away; however, facility staff incorrectly identified R7 as R8.  Facility staff also identified R8, who was still alive, as R7.  The facility sent R7’s body to the funeral home designated for R8.  R8 was administered medication that was documented in R7’s medical chart. 

In April 2020, R7 was a 91-year-old male with multiple medical diagnoses residing in Petitioner’s facility.  CMS Ex. 15 at 1.  In April 2020, R8 was an 89-year-old male also with multiple medical diagnoses residing in Petitioner’s facility.  CMS Ex. 15 at 2.

On April 9, 2020, R7 was transferred from the facility’s Serenity Unit to room V8D after testing positive for COVID-19.  CMS Ex. 15 at 33.  Also on April 9, 2020, R8 was transferred from the facility’s Serenity Unit to room V8W after testing positive for COVID-19.  CMS Ex. 15 at 39; CMS Ex. 16 at 10.

In R8’s progress notes for April 11, 2020, there is an entry for 5:00 a.m. that stated that R8 was found in bed with no pulse, no respiration, and no blood pressure.  The note further stated that R8’s physician was notified and the body was picked up by S.W. Brown and Son Funeral Home.  This entry was later crossed out.  An additional entry in the progress notes concerning an assessment for R8 indicated that R8 was alive.  CMS Ex. 15 at 40; see also CMS Ex. 20 ¶¶ 12-13.

In R7’s progress notes for April 11, 2020, there is an entry for 7:00 a.m. stating that R7 had been given Tylenol at 6:30 a.m.  This entry was later crossed out.  A later entry indicates that R7 expired on April 11, 2020, at 5:00 a.m.  CMS Ex. 15 at 36.

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In an April 17, 2020 written statement, the LPN who notified facility management that a resident had died on April 11, 2020, determined that it was R8 who died by looking at the name plate outside the room and his roster.  The LPN indicated that the deceased resident did not have an identification band.  CMS Ex. 16 at 15; see also CMS Ex. 20 ¶ 19.

In an April 12, 2020 statement, an LPN working on the Valor Unit on April 10 said that many of the residents had been moved from other units into the Valor Unit, and, as a result, the LPN knew that room numbers for the residents were not correct.  The LPN “relied on pictures of residents to administer meds.”  CMS Ex. 16 at 11; see also CMS Ex. 20 ¶ 22.

The facility only learned R7, and not R8, had expired when an R.N. realized the mistake.  In an April 11, 2020 statement, the R.N. wrote:

About 10:00 AM, I was on the “V” wing doing my med pass.  I went to room V8 and gave [R8] his morning meds and I realized that I was told in report this morning that he expired.  I knew [R8] from R/S unit.  So I went to confirm with the other nurses, called an HST from R/S unit and I asked [R8] for his name and he confirmed.

CMS Ex. 16 at 13.

Due to the facility’s error, on April 11, 2020, R7’s remains were sent to the funeral home selected by R8.  See CMS Ex. 15 at 1-2, 5.

In an April 11, 2020 Reportable Event Record/Report, the facility identified the incident as:  “Improper notification of death and applying the wrong ID band on the deceased resident.”  CMS Ex. 16 at 4.

The facility Director of Nursing issued a Final Investigation report of that incident on April 19, 2020, which included the following findings:

[R7 and R8] were both residents from other units who were transferred to Valor Unit on 4/9/2020 and were cohorted in the same room for their Covid 19 positive diagnosis, On 4/11/2020 at approximately 10 AM while the wing nurse was passing meds in room V8, she administered [R8] his medication, and then recalled that the night shift nurse had said in the report that [R8] had expired.  The nurse immediately contacted the Supervisor and the DON.  Upon investigation, it was noted that the night nurse and the night supervisor mistakenly contacted [R8’s] family, documented

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in the wrong chart and also placed the wrong ID band on [R7] when in fact it was [R7] that had expired and not [R8].

CMS Ex. 16 at 16.  The Final Investigation report also listed the following care plan revisions/corrections taken on behalf of the facility:

1. Both [R8’s] and [R7’s] families were immediately contacted and notified of the error.
2. Both the night nurse and the supervisor were immediately contacted and corrected the documentation in the appropriate charts and on the death certificate.
3. The Funeral Home was contacted and [R7’s] family positively identified the remains at the funeral home.
4. [R8’s] family spoke to [R8] to confirm that he was still at our facility.
5. [R8] and [R7] were transferred form [sic] Serenity Unit to Valor Unit on 4/9/2020 approximately 2:30 PM.  Their name tags were placed incorrectly outside their room.  [R8] was at the door bed and [R7] was at the window bed.
6. CNAs took care of both residents in this room.
7. On 4/9/20 and 4/10/20 nurses assigned on shifts were interviewed.  As per their statements, they administered medications looking at the identification sheets with pictures in front of the Medication Administration Record.  Also, nurses were familiar with residents as they were working with them in the past.
8. Night nurse who was working on 4/11/20, when [R7] expired at 5 AM, grabbed the chart looking at the name tag outside the door and that is why the error occurred.
9. In order to prevent this event from occurring again in the future, the following precautionary measures were taken.

a. On all units, resident’s ID bands, room name plates, and unit rosters were all immediately checked and verified for  accuracy.

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b. Policy changes were made in cohorting residents.  We will continue to cohort resident on their own unit based on the type of infection.

c. All resident room name plates have been amended to show “D” or “W” to clearly demonstrate the resident’s location in each room.

CMS Ex. 16 at 16-17.

7. Petitioner was not in substantial compliance with 42 C.F.R. § 483.10(a)(1) because it failed to treat each resident with respect and dignity and care for each resident in a manner and in an environment that promotes maintenance or enhancement of his or her quality of life. 

The SOD in this case generally asserted that the incident on April 11, 2020, involving Petitioner’s failure to properly identify the deceased resident as R7, was a failure on Petitioner’s behalf to ensure the right to dignity was promoted and enhanced.  CMS Ex. 1 at 3.  However, when reviewing the SOD, the focus of the factual allegations as well as Petitioner’s remedial efforts was on the failure of residents to be wearing identification bracelets.  CMS Ex. 1 at 4, 8-13; see also CMS Ex. 16 at 17; CMS Ex. 20 ¶ 19 (“[T]he DON stated that since the event on April 11, 2020, the facility now had in place a process that all residents are to wear ID bands, including residents on the serenity unit, all rosters have been updated, and there were photographs of all residents in their [medical administration record.]”); CMS Ex. 20 ¶¶ 24-26.  The SOD asserted that Petitioner’s “failure placed all residents at risk for not having their rights honored.”  CMS Ex. 1 at 3; see also CMS Ex. 20 ¶ 5. 

In this case, Petitioner spent little effort to defend against this deficiency.  Petitioner does not dispute the facts of the incident and merely argues that CMS “offers no colorable explanation as to how this deficiency had the potential to harm any of [Petitioner’s] residents.”  P. Br. at 33.

I disagree with Petitioner.  The facts alleged in the SOD for this deficiency certainly show the potential for harm for residents of the facility based on the threat of misidentification.

The statutory basis for the cited regulatory violation states:  “A skilled nursing facility must care for its residents in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident.”  42  U.S.C. § 1395i-3(b)(1).  The Secretary interpreted this provision to include a requirement that facilities

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treat residents with respect and dignity as part of the environment that promotes each resident’s quality of life.  The relevant regulation states:

A facility must treat each resident with respect and dignity and care for each resident in a manner and in an environment that promotes maintenance or enhancement of his or her quality of life, recognizing each resident's individuality.  The facility must protect and promote the rights of the resident.

42 C.F.R. § 483.10(a)(1).  The question, therefore, is whether Petitioner’s conduct promoted the maintenance or enhancement of the quality of life for residents.

The regulations explain what “quality of life” means:

Quality of life is a fundamental principle that applies to all care and services provided to facility residents.  Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, consistent with the resident's comprehensive assessment and plan of care.

42 C.F.R. § 483.24 (prefatory language).  In essence, residents must receive necessary care consistent with their plans of care.

I agree with CMS that R7 met an undignified end based on the facility staff’s errors that resulted in the misidentification of R7 with R8 along with the associated problems that the misidentification caused.  Further, it was undignified for R8, the living resident, to be treated as R7 for five hours on the morning of April 11, 2020.  However, more basic to this deficiency was that Petitioner’s conduct had the potential for causing more than minimal harm to R8 in a very tangible way.

The record is clear that on the morning of April 11, 2020, after R7 had passed away and facility staff believed R8 to be R7, facility staff administered a medication to R8 and documented it in R7’s medical chart (although it was later crossed out).  CMS Ex. 15 at 36; see also CMS Ex. 20 ¶ 16.  While the medicine in question was not likely to cause harm (Tylenol), the fact that staff were treating R8 as if he were R7 was dangerous.  This is because the record indicates that R7 took his medication in solid form and did not need liquids thickened, while R8 took medication crushed and needed his liquids thickened like pudding.  CMS Ex. 15 at 6, 37.  The possibility that staff would administer the Tylenol in pill form (or any other medication) to R8 or to provide liquids that had not been thickened, created the potential to cause more than minimal harm.

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I note that the circumstances surrounding the R7/R8 incident on April 11, 2020, were extraordinary due to the COVID-19 pandemic.  Petitioner’s resident population was becoming heavily infected at this time and many deaths would follow.  The confusion involving R7/R8 occurred because staff rightly moved those residents to cohort both of them together after they each tested positive for COVID-19.  However, the confusing situation required staff to double check the identity of residents.  While CMS appears to have focused on the lack of dignity caused by the actions of facility staff, it is clear that CMS’s survey and SOD also show a significant concern that residents in the facility might be misidentified.  That threat of misidentification not only impacts resident dignity but also their right to quality of life.

CMP Amount

8. The $21,393 per-instance CMP imposed on Petitioner is reasonable and appropriate because Petitioner did not dispute any of the relevant statutory and regulatory factors for setting the amount of a CMP. 

When determining whether the amount of a CMP is appropriate, I apply the factors listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  See 42 U.S.C. §§ 1320a-7a(d)(2), 1395i-3(h)(2)(B)(ii)(I); 42 C.F.R. § 488.438(e)(3).  The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f).  The factors listed in 42 C.F.R. § 488.404 include:  1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.  See 42 U.S.C. §§ 1320a-7a(d)(1), (3), 1395i-3(h)(2)(B)(ii)(I).

The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at sections 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2); 498.3(d)(11); see also 42 C.F.R. § 488.438(e)(2) and (3); Alexandria Place, DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC, DAB No. 2186 at 28-29 (2008).

Unless a facility contends that a particular regulatory factor does not support that CMP amount, the ALJ must sustain it.  Coquina Ctr., DAB No. 1860 at 32 (2002).  Thus, the burden is not on CMS to explain its decision-making process or to explain the relative weights assigned to each deficiency to support the CMP amounts imposed.  Once the facility contends that a regulatory factor does not support the CMP amount, CMS must then produce evidence as to that factor.  Coquina Ctr., DAB No. 1860 at 32.

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Here, Petitioner did not dispute any of the factors, other than to dispute the existence of immediate jeopardy in this case.¹³  P. Br. at 34.  As a result, I do not need to discuss the individual factors to uphold the CMP imposed.

Although the CMP imposed is near the top of the range for per-instance CMPs, it is actually a low penalty in comparison to most CMPs imposed on a per-day basis.

Further, had I considered the factors concerning the CMP amount, Petitioner’s culpability related to the 42 C.F.R. § 483.80 deficiency alone is extremely high.  Facility staff on April 20, 2020 and April 21, 2020 were knowingly allowing many residents in the Dementia Unit to interact unmasked and without social distancing.  Those staff members did not attempt to redirect the residents or encourage them to use masks, as required by the IPC and CDC guidelines.  Given that the residents in the Dementia Unit included COVID-positive residents, and that COVID-19 is extremely infectious and deadly to SNF residents, staff’s actions (or rather inaction) endangered those residents’ lives.  Petitioner’s culpability concerning the April 20, 2020 and April 21, 2020 incidents alone fully supports the imposed CMP amount, even if the 42 C.F.R. § 483.10(a)(1) deficiency had not been cited in this case.

V.  Conclusion

I conclude Petitioner was out of substantial compliance with Medicare requirements and uphold the $21,393 CMP imposed on Petitioner.

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Endnotes

¹  “It is the duty and responsibility of the Secretary to assure that requirements which govern the provision of care in skilled nursing facilities . . . are adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public moneys.”  42 U.S.C. § 1395i-3(f)(1).

²  All citations to the Code of Federal Regulations are to the version in effect at the time of the survey unless otherwise indicated.

³  State agencies designate the scope and severity level using a matrix published in the State Operations Manual, chap. 7, § 7400.3.1 (Nov. 16, 2018).  Scope and severity levels of A, B, or C are deficiencies for which CMS cannot impose enforcement remedies. Scope and severity levels of D, E, or F are deficiencies that present no actual harm, but have the potential for more than minimal harm that do not amount to immediate jeopardy.  Scope and severity levels of G, H, or I indicate deficiencies that involve actual harm that do not amount to immediate jeopardy.  Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety.

⁴  Dr. Levy is an internal medicine physician who is board-certified in geriatrics and hospice and palliative medicine.  Dr. Levy is also a Certified Nursing Home Medical Director and holds a doctorate in Clinical Services.  Dr. Levy has been a licensed physician since 1998, has extensively published articles on caring for older adults, has served in professional positions related to palliative medicine since 2006, and regularly provides medical education to physicians concerning the standard of practice, including how to contain the spread of infectious disease within health care facilities.  CMS Ex. 21 ¶¶ 2-3; CMS Ex. 22.

⁵  Dr. Nahass is a board-certified infectious diseases physician who is president of the largest infectious disease health care organization in New Jersey.  P. Ex. 10 ¶¶ 1-2; P. Ex. 11 at 2.  Dr. Nahass has been a licensed physician since the early 1980’s and has focused on researching, teaching, and providing care in the field of infection disease and infection prevention.  P. Ex. 10 ¶ 3; P. Ex. 11 at 2, 5.  Dr. Nahass has served as a medical director for infection control at nursing facilities and, as the hospital epidemiologist at the Robert Wood Johnson University Hospital, led the medical response at that facility to COVID-19.  P. Ex. 10 ¶ 2.  He has published a number of articles on COVID-19.  P. Ex. 10 ¶ 3; P. Ex. 11 at 12-13.

⁶  Although the version of this document was updated nearly three weeks after the survey took place, I will apply it in this case because Petitioner submitted it, and CMS did not object to it as an exhibit.

⁷  During SNF surveys, the surveyors will designate each resident with a number.  R9 refers to Resident 9.  In the interest of protecting privacy, this decision will use the survey designations for residents.

⁸  Surveyor Cronin has been a registered nurse (R.N.) since 1993 and holds an Associate of Science degree in Nursing and a Bachelor of Science degree in Medical Technology.  CMS Ex. 19 ¶ 1; CMS Ex. 23 at 3.  In addition to serving as an R.N. for six years, Surveyor Cronin has approximately 20 years of experience as a surveyor of nursing facilities.  CMS Ex. 23 at 1-2.

⁹  The Secretary revised the Part 483 regulations concerning SNF conditions of participation in 2016.  Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (Jul. 13, 2017) (technical corrections).  The infection prevention and control regulation currently promulgated in 42 C.F.R. § 483.80 was formerly found in 42 C.F.R. § 483.65.  In assessing compliance under § 483.80 in this case, I consider case decisions analyzing the former § 483.65.

¹⁰  Shawna Maraj is a Licensed Nursing Home Administrator in several states, served as the interim administrator for several nursing facilities during the COVID-19 pandemic, and holds a Bachelor of Science degree in Business Administration/Health Service Administration.  P. Ex. 8 ¶¶ 1-2; P. Ex. 9.

¹¹  Petitioner fully understood how infectious and deadly COVID-19 is for SNF residents.   At the facility, from March 25, 2020 to April 22, 2020, 119 out of 239 residents were confirmed as positive for COVID-19, and there had been 46 COVID-19 deaths.  CMS Ex. 19 ¶ 7.

¹²  The SOD included additional allegations, unrelated to the incidents observed on April 20, 2020 and April 21, 2020 in the Dementia Unit, to support a deficiency finding under 42 C.F.R. § 483.80.  CMS Ex. 1 at 17-20.  Based on my review of this case, the April 20, 2020 and April 21, 2020 incidents clearly show deficient conduct that imperiled numerous residents.  This conduct alone is sufficient to support the CMP imposed in this case.  Therefore, I do not discuss the other allegations in the SOD related to 42 C.F.R. § 483.80.  See Perry Cnty. Nursing Ctr. v. U.S. Dep’t of Health & Human Services, 603 F. App’x 265, 271 (5th Cir. 2015) (agreeing that the regulations require ALJs to review only those findings that are material to the outcome of a case); Claiborne-Hughes Health Ctr. v. Sebelius, 609 F.3d 839, 847 (6th Cir. 2010); Rockcastle Health and Rehab. Ctr., DAB No. 2891 at 23-24 (2018); Carrington Place of Muscatine, DAB No. 2321 at 20-21 (2010); Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 6 n.5 (2010), aff’d Senior Rehab. & Skilled Nursing Ctr. v. Health & Human Servs., 405 Fed. App’x 820 (5th Cir. 2010); Carrington Place of Muscane, DAB No. 2321 at 20-21 (2010).

¹³  While I have no authority to review CMS’s determination that immediate jeopardy exists in this case, I note for purposes of the penalty (i.e., considering the scope and severity of the deficiencies) that my findings concerning the 42 C.F.R. § 483.80 deficiency would have certainly support CMS’s immediate jeopardy determination.  The highly infectious and deadly nature of COVID-19, especially in the nursing home setting, makes the situation observed in the Dementia Unit on April 20, 2020 and April 21, 2020, one that was likely to cause serious harm to residents.